ACP InternistWeekly

In the News for the Week of 10-18-11

Highlights

Annual mammography may result in many false positives

After 10 years of annual mammography, more than half of women will receive at least one false-positive screen, and 7% to 9% will receive a false-positive biopsy recommendation, according to a study. More...

Risk for esophageal adenocarcinoma with Barrett's esophagus may be lower than originally thought

Patients with Barrett's esophagus may have a lower risk for esophageal adenocarcinoma than originally thought, according to a new study. More...

Test yourself

MKSAP Quiz: 6-month history of dry eye

This week's quiz asks readers to evaluate a 68-year-old man with a 6-month history of dryness in his eyes. More...

Diabetes

Diabetes education programs show mixed results

Educational programs for patients with uncontrolled diabetes showed some success but overall had mixed results in three recent trials. More...

For the record

Clarification to a previous issue

From the College

Remembering and fostering long-term relationships with patients

Fred Ralston Jr., MD, MACP, ACP's immediate past president and a practicing internist in Fayetteville, Tenn., blogs this month at KevinMD.com on remembering and fostering long-term relationships with patients as we make modifications to our health care system. More...

New online Special Interest Groups discussion forum launched

ACP members are invited to participate in ACP's Special Interest Groups, a private online community that allows members to share experiences, questions, and creative solutions with like-minded physicians at their own convenience. More...

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Highlights

Annual mammography may result in many false positives

After 10 years of annual mammography, more than half of women will receive at least one false-positive screen, and 7% to 9% will receive a false-positive biopsy recommendation, according to a study.

Results also indicated that biennial screening appears to reduce these risks but may be associated with a small and not statistically significant absolute increase in the probability of late-stage cancer diagnoses. Researchers conducted a prospective cohort study among 169,456 women who underwent first screening mammography at age 40 to 59 years between 1994 and 2006 and 4,492 women with incident invasive breast cancer diagnosed between 1996 and 2006. Results appeared in the Oct. 18 Annals of Internal Medicine.

The study included 386,799 mammograms from 169,456 women. Nearly half (47.7%) of the women had only one screening mammogram; 11.8% had 5 or more. In the cohort, 9,331 women (5.5%) had only one year of follow-up and 4,891 (2.9%) were observed for 10 or more years.

Most initial mammograms (78.9%) were for women aged 40 to 49. Among subsequent mammograms, 55.6% occurred at an approximately annual screening interval (within 9 to 18 months of a prior mammogram) and 27.6% occurred approximately biennially (within 18 to 30 months of a prior mammogram). The remainder of mammograms occurred at longer than biennial intervals.

The likelihood of being recalled due to a false positive was 16.3% at first and 9.6% at subsequent mammography, researchers reported. Probability of false-positive biopsy recommendation was 2.5% at first examinations and 1.0% at subsequent ones. The availability of comparison mammograms halved the odds of a false-positive recall (adjusted odds ratio, 0.50 [95% CI, 0.45 to 0.56]).

When screening began at age 40, the cumulative probability of a woman receiving at least one false-positive recall after 10 years was 61.3% (95% CI, 59.4% to 63.1%) with annual screening and 41.6% (95% CI, 40.6% to 42.5%) with biennial. Cumulative probability of false-positive biopsy recommendation was 7.0% (95% CI, 6.1% to 7.8%) with annual and 4.8% (95% CI, 4.4% to 5.2%) with biennial screening. Estimates were similar when screening began at age 50.

The authors noted that although there was no statistically significant absolute difference in the overall proportion of late-stage cancer between biennial and annual screening, the findings could not exclude an increase in late-stage cancer as great as 7.8% among women in their 40s and 5.7% among women in their 50s. The study's small sample size of breast cancer resulted in broad confidence intervals, and a larger study is required to exclude the possibility of a clinically significant increase in late-stage cancer with less frequent screening.

The authors also noted that most mammograms in this analysis were film-screen examinations. Digital screening mammography is rapidly becoming the predominant screening method, with 76.2% of accredited facilities using full-field digital machines by May 2011.

A second study in the same issue of Annals found that digital and film-screen mammography offered comparable results in community practice, but that digital mammography was better at detecting estrogen receptor-negative tumors and cancer in extremely dense breasts. Researchers conducted a prospective cohort study of 329,261 women aged 40 to 79 years who underwent 869,286 mammograms (231,034 digital; 638,252 film-screen).

Cancer detection rates and tumor characteristics were similar for digital and film-screen mammography, but the sensitivity and specificity of each modality varied by age, tumor characteristics, breast density, and menopausal status. Compared with film-screen mammography, the sensitivity of digital mammography was significantly higher for women aged 60 to 69 years (89.9% vs. 83.0%; P=0.014) and those with estrogen receptor-negative cancer (78.5% vs. 65.8%; P=0.016). The digital test's sensitivity was borderline significantly higher for women aged 40 to 49 years (82.4% vs. 75.6%; P=0.071), those with extremely dense breasts (83.6% vs. 68.1%; P=0.051), and pre- or perimenopausal women (87.1% vs. 81.7%; P=0.057). It was slightly lower for women aged 50 to 59 years (80.5% vs. 85.1%; P=0.097). The specificity of digital and film-screen mammography was similar by decade of age, except for women aged 40 to 49 years (88.0% vs. 89.7%; P<0.001).

An editorial about both studies concluded that annual mammography is less efficient than biennial screening, and also that digital technology is probably no better than film-based mammography for preventing advanced disease. The editorialist wrote, "Given the absence of clear reductions in breast cancer deaths, the higher rates of false-positive results, and the greater detection of in situ tumors of unknown clinical significance, the generalization of digital mammography may reduce the efficiency of breast screening."

Risk for esophageal adenocarcinoma with Barrett's esophagus may be lower than originally thought

Patients with Barrett's esophagus may have a lower risk for esophageal adenocarcinoma than originally thought, according to a new study.

Researchers in Denmark performed a national population-based cohort study to try to obtain accurate data on the incidence of esophageal adenocarcinoma and high-grade dysplasia in patients who have Barrett's esophagus. The study used Danish databases to collect information on all patients with Barrett's esophagus from 1999 through 2009. The main outcome measures were incidence rates for adenocarcinoma and high-grade dysplasia. The authors also calculated standardized incidence ratios using Danish cancer rates during the same time period to measure relative risk. The study results appear in the Oct. 13 New England Journal of Medicine.

Overall, 11,028 patients were found to have Barrett's esophagus (66.8% men vs. 33.2% women; median age at baseline, 62.7 years). The median follow-up time was 5.2 years. One hundred thirty-one patients were diagnosed with new adenocarcinoma in the first year after an index endoscopy and 66 new cases were diagnosed in subsequent years (incidence rate, 1.2 cases per 1,000 person-years; 95% CI, 0.9 to 1.5 per 1,000 person-years). Patients with Barrett's esophagus had a relative risk of 11.3 (95% CI, 8.8 to 14.4) for adenocarcinoma compared with the general population, while the annual risk was 0.12% (95% CI, 0.09 to 0.15). Patients with low-grade dysplasia on initial endoscopy were at higher risk for adenocarcinoma than patients without dysplasia.

The authors noted that more cases of Barrett's esophagus were diagnosed during the study period because of increased awareness and that it was difficult to classify all patients according to stage of dysplasia, among other limitations. However, they concluded that although Barrett's esophagus is a significant risk factor for esophageal adenocarcinoma, the absolute annual risk in this study was substantially lower than assumed in current guidelines for routine surveillance (0.12% vs. 0.5%). "The results of our study suggest that the risk of esophageal adenocarcinoma among patients with Barrett's esophagus is so minor that in the absence of dysplasia, routine surveillance of such patients is of doubtful value," they wrote.

The author of an accompanying editorial agreed, pointing out that although endoscopy accurately detects Barrett's esophagus, the finding has become less significant as more is learned about its biological characteristics. "Currently available evidence has not shown that the current strategy of screening and surveillance of patients with Barrett's esophagus is cost-effective or reduces mortality from esophageal adenocarcinoma," he wrote.

Diabetes

Diabetes education programs show mixed results

Educational programs for patients with uncontrolled diabetes showed some success but overall had mixed results in three recent trials.

The most successful of the programs randomized 222 patients with a mean A1c of 9.0% (half type 1 diabetics and half type 2) to one of three arms: (1) a five-session manual-based, educator-led structured group intervention with cognitive behavioral strategies; (2) an educator-led group education program; or (3) unlimited individual nurse and dietitian education sessions for six months. All of the groups showed significant improvements in A1c, but the patients who received structured behavioral education made the greatest improvements: an A1c drop of 0.8% compared to 0.4% in the other groups (P=0.04 for group x time interaction). The study authors concluded that the structured behavioral intervention was effective and could successfully be implemented by nurses and dieticians, although they noted that sustainability of the results should be investigated.

However, another study, also published online by Archives of Internal Medicine on Oct. 10, found greater success with individual education than group education. This trial included 623 type diabetics with an A1c of at least 7%. They were randomized to group education using the US Diabetes Conversation Map program (totaling eight hours), three hours of individual education or usual care. Again, all of the groups lowered their A1cs, but the individual group had a significantly bigger drop (−0.51% compared to −0.27% with group education and −0.24% with usual care; P=0.01 for difference between groups). The authors concluded that the results support existing Medicare reimbursements for individual education, and they noted that the type of group education, and the educators' lack of experience with conversation maps, may have been one cause of the difference.

The final study enrolled 201 patients and randomized them to either a 24-minute video and five sessions of telephone coaching by a trained diabetes nurse or a 20-page brochure from the National Diabetes Education Program. The mean A1c at the start of the study was 9.6%, and it decreased to 9.1% six months after the intervention, but no significant difference was found between the groups. The authors noted that their study population was particularly difficult to treat; in addition to having a high baseline A1c, the patients were predominately poor and uninsured, and the study was undertaken at the start of the recession. They concluded that the telephone coaching was insufficient and that more intensive interventions may be necessary, particularly for disadvantaged patients.

A commentary that accompanied the three studies struggled to pull overarching conclusions from the differing findings. The education strategies can't really be directly compared, especially since the amount of time educators spent with patients varied dramatically, with more time investment apparently being associated with greater success. Also, none of the findings should lead to rejection of these approaches for newly diagnosed patients, the commentary said, since most trial participants had already had the disease for many years. Another accompanying commentary said that the studies point to the need for a more standardized definition of health coaching, with training requirements and credentialing standards for health and wellness coaches.

Readmissions

There's no definitive evidence that any single intervention reduces 30-day hospital readmissions, a literature review concluded.

Researchers reviewed 43 studies that tested discharge interventions using an experimental or observational design and reported relative readmission outcomes for an intervention and control cohort.

They found that flaws in the literature prevented them from concluding that any single intervention was effective. For example, some study interventions weren't well described and couldn't be included in a meta-analysis. Many of the studies were single-institution assessments that lacked experimental designs while those that were randomized did not consistently show a significant effect. Several common interventions have not been studied outside of multicomponent "discharge bundles." Results appeared in the Oct. 18 Annals of Internal Medicine.

Predischarge patient education and discharge planning were the most commonly evaluated interventions, appearing in 22 of the 43 studies. Of the 43 studies, 16 were randomized, controlled trials. Five of them documented statistically significant improvements in readmissions within 30 days. One of the five consisted of a single intervention in which high-risk patients received early discharge planning or usual care. Those randomly assigned to the treatment group experienced an absolute 11% reduction in 30-day rehospitalization.

Four randomized studies demonstrated statistically significant beneficial effects of multicomponent discharge bundles. Interventions common to these studies were the postdischarge telephone call and patient-centered discharge instructions. However, two randomized trials that included these two interventions among others in a bundle did not demonstrate significant reductions in 30-day rehospitalization. The other two randomized trials of follow-up calls as an isolated intervention also did not find a significant effect.

The authors wrote, "In this systematic review of studies evaluating interventions to reduce readmission within 30 days of hospital discharge, we did not identify a discrete intervention or bundle of interventions that appears to reliably reduce rehospitalization.... Overall, observational designs predominated, and studies were characterized by significant heterogeneity of intervention content and context. This has been acknowledged to be a common limitation in the patient safety literature."

Still, promising avenues remain for study, including discharge instructions and telephone follow-up. Even though Medicare is expected to penalize hospitals with higher-than-average readmission rates, "[T]he current evidence base may not be adequate to facilitate change even for highly incentivized hospitals, and reconsideration of planned penalties may be reasonable," the authors concluded.

Education

Upcoming conference examines patient-centered policy, practice

The ERCI Institute and the FDA will co-organize an upcoming conference titled "Patient-Centeredness in Policy and Practice," to be held Nov. 29-30 in Silver Spring, Md.

ACP's EVP and CEO, Steven E. Weinberger, MD, FACP, will present at the conference, which will examine research that promotes and evaluates the effectiveness of moving the health care system toward patient-centeredness. Other speakers and moderators include Margaret Hamburg, MD, FACP, commissioner of the FDA; Carolyn Clancy, MD, MACP, director of the Agency for Healthcare Research and Quality; and Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health. The conference will attempt to determine what patient-centeredness means, which programs to develop it are working, whether patient-centeredness has staying power, and whether a business case supports it.

The conference is free, but advance registration is required and space is limited. More information and registration are available online.

For the record

Clarification to a previous issue

In the Oct. 4 issue of ACP InternistWeekly, the "Test yourself" question involved initiation of statin treatment in a diabetic and hypertensive patient currently being treated with amlodipine. The correct answer was treatment with simvastatin, with the critique section noting that up to 40 mg daily might be needed to achieve adequate LDL reduction.

In June 2011, the FDA issued new guidelines indicating that simvastatin dosing in patients taking amlodipine should not exceed 20 mg daily due to a drug-drug interaction and an increased risk of rhabdomyolysis. If simvastatin is selected in this case, it should be limited to 20 mg daily or less with appropriate monitoring of clinical and laboratory parameters. Other statins are not known to have a clear interaction with amlodipine and would be reasonable alternatives in this patient.

From the College

Remembering and fostering long-term relationships with patients

Fred Ralston Jr., MD, MACP, ACP's immediate past president and a practicing internist in Fayetteville, Tenn., continues his monthly column at KevinMD.com, one of the Web's leading destinations for provocative physician commentary. This month's post looks at the importance of remembering and fostering long-term relationships with patients as we make modifications to our health care system.

New online Special Interest Groups discussion forum launched

ACP members are invited to participate in ACP's Special Interest Groups, a private online community that allows members to share experiences, questions, and creative solutions with like-minded physicians at their own convenience.

The special interest groups forum is free and exclusive to ACP members. Discussion group topics include hospital medicine, small practices, work/life balance, ACOs/new practice models, emerging technologies and physician educators. Signup is required and more information is available online.

The ACP Foundation held a National Stakeholder Conference on Tuesday, Sept. 27, 2011 to address gaps in the management of atrial fibrillation and the prevention of stroke. The meeting was the culmination of the work of the National Steering Committee over the past 10 months.

The meeting presented a unique and timely opportunity for key leaders to participate in creating change that will potentially lead to a reduction in atrial fibrillation-related strokes. Participants discussed ways to bridge gaps in care management of atrial fibrillation through development and integration of innovative interventions into current care processes.

Stakeholders represented a diverse group of organizations and expertise, bringing together insights necessary to identify solutions to address this pressing health issue.

MKSAP Answer and Critique

The correct answer is A) Conjunctival biopsy. This item is available to MKSAP 15 subscribers as item 19 in the Dermatology section. More information about MKSAP 15 is available online.

This patient probably has ocular cicatricial pemphigoid based upon the history of dryness of the eyes and evidence of conjunctival scarring (trichiasis and symblepharon). Ocular pemphigoid can result from several immunologic phenomena, including linear IgA deposition, linear IgG deposition resembling bullous pemphigoid, or linear IgG deposition resembling epidermolysis bullosa acquisita. This disorder can be sight-threatening and, therefore, warrants accurate diagnosis with biopsy and appropriate histopathologic studies. Biopsy of the conjunctiva will reveal subepithelial separation below the basement membrane, and direct immunofluorescence will reveal linear deposition of IgG and C3 at the basement membrane zone. Once the diagnosis is confirmed, aggressive management with corticosteroids and cyclophosphamide is indicated. However, treatment with prednisone and cyclophosphamide should wait until confirmation of the diagnosis.

Herpes zoster ophthalmicus is a complication of varicella-zoster virus infection involving the ophthalmic division of the fifth cranial nerve. Most patients with herpes zoster ophthalmicus will experience headache and fever associated with pain or hypesthesia in the affected eye and forehead. With outbreak of the characteristic cutaneous vesicles, patients typically develop hyperemic conjunctivitis. Severely ill patients are often treated with intravenous acyclovir, but less ill patients may be successfully treated with oral valacyclovir or famciclovir. In the absence of the typical vesicular eruption of herpes zoster, there is no indication for intravenous acyclovir.

Bacterial conjunctivitis is caused by a range of gram-positive and gram-negative organisms and is characterized by presentation in one eye, but this condition often spreads to involve the other eye and is associated with purulent discharge. Empiric treatment with broad-spectrum topical antibiotics is indicated in patients with bacterial conjunctivitis. The patient's 6-month history of ocular symptoms is not compatible with an acute bacterial conjunctivitis, and treatment with a topical antibiotic should not take precedence over a conjunctival biopsy.

Key Point

Ocular cicatricial pemphigoid is sight-threatening and warrants accurate diagnosis with biopsy and appropriate histopathologic studies, as well as aggressive management with corticosteroids and cyclophosphamide.

Test yourself

A 24-year-old woman undergoes routine evaluation. She is pregnant at 12 weeks' gestation. Medical history is notable for homozygous sickle cell anemia (Hb SS). She has had multiple uncomplicated painful crises treated at home with hydration, nonopioid analgesia, and incentive spirometry. Following a physical exam and lab studies, what is the most appropriate management?

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